• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail

Refusal Details as Recorded in OASIS by FDA

for Refusal 110-0577676-5/1/1

Manufacturer FEI3005942158
Manufacturer NameInnovatek  
Manufacturer Address line 18th Floor No. 13, Kong Sanhong Center  
Manufacturer Address line 2  
Manufacturer's City151-153 Hoibun Road Kwun Tong Kowloon  
Manufacturer Province/State  
Manufacturer Country/AreaHong Kong SAR  
Product Code95RFY  
Importer's Product DescriptionDVD-R, DVD+R, DVD-RAM, DVD+RW, DVD-RW RECORDER, UTILITY/PERI  
Refusal Date08-Dec-2006  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 110-0577676-5/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO REGISTR   536(a); Failure to file initial report   The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).